Comparing spinal anesthesia and general anesthesia in patients with ankle fracture
Phase 1
- Conditions
- Ankle fracture needing surgical fixationTherapeutic area: Diseases [C] - Injuries, poisonings, and occupational diseases [C21]
- Registration Number
- EUCTR2020-003903-32-FI
- Lead Sponsor
- niversity of Oulu
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 110
Inclusion Criteria
ankle fracture needing surgical repair
age 18 years or more
cognition suitable to understand the study protocol and give informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 55
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 55
Exclusion Criteria
Contraindications to spinal anesthesia
other injuries operated at the same time
marked cognitive or psychiatric condition
marked substance misuse
marked neuropathic condition in the operated leg
chronic opioid medication
pregnancy or lactation
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method